ViaLase, Inc. announced that the first patient has received treatment with its femtosecond laser trabeculotomy procedure for glaucoma as part of an ongoing U.S investigational device exemption (IDE) clinical trial.
First, explain the concept behind an IDE trial.
An IDE is a regulatory submission to the FDA enabling an investigational device (such as ViaLase’s technology) to be evaluated for safety and effectiveness in a clinical trial.
Per the federal agency: Such clinical studies are most often conducted to support a premarket approval (PMA) submission of a device for FDA clearance.
- And importantly: All clinical evaluations of investigational devices (unless otherwise exempted) are required to have an approved IDE in place prior to a study’s initiation.
See here for real-world examples of what happens when this protocol isn’t adhered to.
And ViaLase’s technology isn’t approved yet, right?
Not in the United States (it actually already received a CE mark in the European Union last year for primary open-angle glaucoma [POAG]).
Noted. Now tell me about it.
Known as the ViaLuxe Laser System, ViaLase’s technology delivers tightly focused, optical coherence tomography (OCT)-guided femtosecond laser pulses throughout the cornea and across the anterior chamber to the iridocorneal angle.
- How: Via femtosecond laser image-guided high-precision trabeculectomy (FLigHT).
Explain this.
During FLigHT, a surgeon noninvasively creates a single channel—measuring 500 μm wide by 200 μm high—through the trabecular meshwork (TM) and into Schlemm’s canal.
Importantly: This is an incision-free approach, performed without any damage to adjacent tissue (avoiding the potential risk of lowering intraocular pressure (IOP]).
- Check out a visual of the system in action (and a step-by-step look at the process).
Alrighty, now to this IDE study—give me the rundown.
Keep in mind: The U.S.-based pivotal study—which is separate from the company’s previous VIA-002 pivotal trial that evaluated an original prototype of the laser system—was planned in consultation with the FDA to support an eventual U.S. clearance and commercialization of the ViaLuxe System.
- The design: A prospective, multicenter, randomized, controlled trial
- The purpose: To compare the ViaLase procedure versus selective laser trabeculoplasty (SLT) in reducing IOP.
- The participants: 152 adult patients diagnosed with POAG
As for specific outcome measures—the company has not yet released those details.
Any timeframe yet on when results might be available?
None so far. But when that data does come in—it’ll be significant, according to Thomas W. Samuelson, MD, the study’s medical monitor as well as found partner and attending surgeon at Minnesota Eye Consultants.
“For the first time, we will have randomized data comparing a next-generation incision-free canal procedure against SLT,” he stated, with the potential to reshape the glaucoma treatment paradigm.
In the meantime, is there any prior research on the system to be aware of?
There is! In 2023, ViaLase reported (positive) 12-month and 24-month data from its first-in-human (FIH) study evaluating FLigHT performed with the ViaLux system for POAG.
A brief recap of those:
- A reduction in mean IOP was noted at 12 months, with 100% of treated eyes not needing further IOP-lowering treatment and no evidence of scarring at the treatment site
With FLigHT demonstrating a favorable safety profile, 24-month results showed a 34% reduction in mean IOP—and no serious adverse events related to treatment.